SCREEN Holdings Co., Ltd. have recently received third-party certification for its Rakusai Site (Fushimi-ku, Kyoto) under ISO 13485, the international standard for quality control methods for medical devices. With this certification, we will continue to develop products under an international quality control system for the design, manufacture, and sale of medical devices, and to prepare for overseas expansion.
ISO 13485 is an international standard for quality management systems specifically for the medical device industry. The standard has been adopted as the basis for quality management methods in medical device regulations around the world, including Japan.

Certification Registration Details

Applicable Standards EN ISO 13485:2016(ISO 13485:2016)
Corporate Name SCREEN Holdings Co., Ltd.
Office Name Rakusai Site
Location 322 Furukawa-cho Hazukashi Fushimi-ku, Kyoto 612-8486 JAPAN
Registration Date 2023-04-03
Registration Number Q5 002530 0003
Certification Body:TÜV SÜD Japan Ltd.


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SCREEN Holdings Co., Ltd. Medical Device Project
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